The following data is part of a premarket notification filed by Choice Spine, Llp with the FDA for Choice Spine Cervical Interbody Spacer System Choice Spine Cervical Interbody Spacer.
| Device ID | K091531 |
| 510k Number | K091531 |
| Device Name: | CHOICE SPINE CERVICAL INTERBODY SPACER SYSTEM CHOICE SPINE CERVICAL INTERBODY SPACER |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | CHOICE SPINE, LLP 306 ERIN DRIVE Knoxville, TN 37919 |
| Contact | G.todd Hawkins |
| Correspondent | G.todd Hawkins CHOICE SPINE, LLP 306 ERIN DRIVE Knoxville, TN 37919 |
| Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-05-26 |
| Decision Date | 2009-11-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840996146548 | K091531 | 000 |
| 10840642103359 | K091531 | 000 |
| 10840642103342 | K091531 | 000 |
| 10840642103335 | K091531 | 000 |
| 10840642103328 | K091531 | 000 |
| 10840642103311 | K091531 | 000 |
| 10840642103304 | K091531 | 000 |
| 10840642103298 | K091531 | 000 |
| 10840642103281 | K091531 | 000 |
| 10840642103274 | K091531 | 000 |
| 10840642103267 | K091531 | 000 |
| 10840642103182 | K091531 | 000 |
| 10840642103175 | K091531 | 000 |
| 10840642103168 | K091531 | 000 |
| 10840642103151 | K091531 | 000 |
| 10840642103144 | K091531 | 000 |
| 10840642103137 | K091531 | 000 |
| 10840642103120 | K091531 | 000 |
| 10840642103366 | K091531 | 000 |
| 10840642103373 | K091531 | 000 |
| 10840642103380 | K091531 | 000 |
| 00840996146531 | K091531 | 000 |
| 00840996146524 | K091531 | 000 |
| 00840996146517 | K091531 | 000 |
| 00840996146500 | K091531 | 000 |
| 00840996146494 | K091531 | 000 |
| 00840996146487 | K091531 | 000 |
| 10840642103496 | K091531 | 000 |
| 10840642103489 | K091531 | 000 |
| 10840642103472 | K091531 | 000 |
| 10840642103465 | K091531 | 000 |
| 10840642103458 | K091531 | 000 |
| 10840642103441 | K091531 | 000 |
| 10840642103434 | K091531 | 000 |
| 10840642103427 | K091531 | 000 |
| 10840642103410 | K091531 | 000 |
| 10840642103403 | K091531 | 000 |
| 10840642103397 | K091531 | 000 |
| 10840642103113 | K091531 | 000 |